Sie sind hier: Home > Regional > !#platzhalterstadtname!# >

!#platzhalterdienstname!#

Anzeige
Filter

Weitere: Naturwissenschaften und Forschung: 4 Jobs in Bad Wurzach

Berufsfeld
  • Weitere: Naturwissenschaften und Forschung
Branche
  • Pharmaindustrie 3
  • Sonstige Branchen 1
Berufserfahrung
  • Mit Berufserfahrung 4
  • Mit Personalverantwortung 2
  • Ohne Berufserfahrung 1
Arbeitszeit
  • Vollzeit 4
Anstellungsart
  • Feste Anstellung 4
Weitere: Naturwissenschaften und Forschung

Office Head Global CMC RA

Fr. 03.12.2021
Biberach an der Riß, Ingelheim am Rhein
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.   Lead an Office of CMC RA-Managers responsible for biological & ATMP development projects and approved biological products: In your role as office head, you have global responsibility for CMC regulatory topics pertaining to development and approved products within the office. You supervise, train and guide the CMC RA managers and actively support their functional as well as personal development in accordance to Talent Management principles. Furthermore, you define goals within the office and monitor the implementation of these. You are responsible for capacity steering and product/project assignments. In addition, you conduct the annual performance review with your direct reports. With your expertise, you contribute to development, innovation and continuous improvement of processes and standards within Regulatory Affairs. You represent Global CMC Regulatory Affairs on general, inter-disciplinary strategic projects and represent BI on external industry groups. Moreover, you maintain up-to-date knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA and Emerging Markets). In addition to your responsibilities as office lead, you also manage global CMC regulatory tasks during development and product life cycle.  Global management of CMC regulatory tasks and responsibilities in development as well as during product life cycle: In this function, you represent the department in international project teams and provide regulatory advice regarding global CMC regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities.  It is your responsibility to guide project teams to prepare high quality global registrations documents and responses to health authority requests and ensure that timelines will be met. In addition, you plan, define, review and compile global Module 3 documentation for Clinical Trial Applications, Marketing Authorization Applications as well as for post approval CMC activities (e.g. CMC changes and renewals). Furthermore, you will review CMC documentation for in-licensing products. Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology First experience in team management In depth global CMC regulatory experience for biologicals and/or ATMPs as well as for drug-device combination products Experience in CMC development and/ or production/control of biologicals and /or ATMPs with sound scientific understanding of products and processes Ability to lead and motivate people, set directions and manage changes Inter-disciplinary, innovative and strategic thinking Strong communication skills Strong organizational skills, excellent prioritization and time management skills Risk identification and problem-solving skills Fluent in English (written and spoken); German language would be a plus This is where you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.
Zum Stellenangebot

Head of Quality Operations - GMP (m/w/d)

Mi. 01.12.2021
Biberach an der Riß
Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie ebenso wie in der Biotechnologie und Medizintechnik kennen wir die entscheidenden Ansprechpartner, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Experten, um sich beruflich zu entwickeln und an ihrer Karriere zu arbeiten. Ihnen als Kandidat bieten wir dabei als spezialisierte Personalberatung mit einem internationalen Netzwerk entscheidende Vorteile - und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.Übernahme einer hochkarätigen Führungsaufgabe des Bereiches Quality Operations mit kontinuierlicher Verbesserung von Qualität und EffizienzVerantwortlich für die Sicherstellung der Einhaltung gesetzlicher Richtlinien im Rahmen der Qualitätskontrolle und -sicherheit (EU-GMP-Leitfaden, AMWHV und internationale Qualitätsrichtlinien)Idealerweise die Ausübung der Funktion der Qualified Person § 15 AMG und Verantwortung für die Qualität der Arzneimittel im Bereich der Herstellung, Prüfung und des Inverkehrbringens (§19AMG) sowie ChargenfreigabeFestlegung von Arbeitszielen und deren Kontrolle und BeurteilungDurchführung der Personalplanung und daraus resultierenden PersonalmaßnahmenProaktive Umsetzung der Unternehmenspolitik und -ziele im eigenen FachbereichEntwicklung von Konzepten zur mittel- und langfristigen ZukunftsplanungRepräsentation in Projekten intern und bei externen KundenErfolgreich abgeschlossenes naturwissenschaftliches Studium z.B. Biotechnologie, Biochemie oder PharmazieFundierte Fachkenntnisse in Bezug auf GMP- Bedingungen sowie der aktuellen Gesetze und VerordnungenProfunde Berufserfahrung im Bereich der biotechnologischen und pharmazeutischen Industrie mit Schwerpunkt Qualitätskontrolle und -sicherungIdealerweise behördliche Zulassung als sachkundige Person (Qualified Person) § 15 AMG (3) im Bereich Impfstoffe und nach § 15 AMG (2) im Bereich PharmazeutikaDurchsetzungsstarke Führungspersönlichkeit mit hoher fachlicher und sozialer Kompetenz- Ausgeprägte Kommunikationsfähigkeit und versierter Umgang mit Behörden und KundenErfahrung in erfolgreichem Durchführen von Audits und InspektionenSehr gute verhandlungssichere Kenntnisse der deutschen und englischen Sprache in Wort und SchriftAbwechslungsreiche Tätigkeit in einem renommierten UnternehmenAttraktive, leistungsorientierte Vergütung & SozialleistungenEin hoch motiviertes Team und ein offener KommunikationsstilEine unbefristete AnstellungDienstwagenregelung
Zum Stellenangebot

Head of Biobanking

Di. 30.11.2021
Biberach an der Riß
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.THE POSITIONBoehringer Ingelheim’s biobank has a high impact for the development of innovative medicines by providing a large number of high-quality biospecimens and associated data for future research use. You are responsible to drive, promote and execute the global biobanking strategy with the focus to optimally support our portfolio. You lead a team of biobanking managers responsible for the operational implementation of the strategy. Furthermore, you are well cross-linked within the biobanking community and serve as reliable info-hub for all biobanking related topics. Discover our Biberach site: Please include a cover letter with your application.  One of your key responsibilities will be the further development of Boehringer Ingelheim's global biobanking strategy and processes in alignment with stakeholders including promotion as well as execution of the strategy. You build and use networks within Boehringer Ingelheim and the international biobanking community to discuss concepts and implement advances in biobanking. Moreover, you take care of a functional and compliant infrastructure to ensure a high-quality resource of human biospecimens and their long-term availability and usage, be it Boehringer Ingelheim internal or with external providers for biobanking services. You standardize, optimize and monitor concepts and processes for biobanking including ethical and compliance aspects. Furthermore, you lead a team of experienced biobanking managers responsible for maintenance and improvement of Boehringer Ingelheim’s biobanking activities.  You will be the main contact person and Info Hub for any biobanking related topic at Boehringer Ingelheim. In particular, you advice project teams to implement a fit-for-purpose biobanking strategy. PhD in Biology, Biochemistry, Life Sciences or a related field with several years of proven working experience in the biobanking field, preferably within the pharmaceutical industry Profound knowledge of and experience in the pharma environment as well as good understanding of clinical biomarker research and biomarker application in human studies Personnel management skills with proven track record Proficient communication and negotiating skills to communicate effectively and in an integrative manner with internal and external experts, stakeholders, opinion leaders and CROs/vendors Process-oriented thinking and acting and ability to take decisions Fluent in written and spoken English This is where you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.
Zum Stellenangebot

Head of Laboratory - Bioanalysis/ Principal Scientist

Do. 25.11.2021
Biberach an der Riß
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.THE POSITIONIs bioanalysis your true passion? – We have an exciting position open at Boehringer-Ingelheim in DMPK Germany for you – Check it out! Discover our Biberach site: In your new role as Head of Laboratory – Bioanalysis / Principal Scientist you will assume full responsibility for coordinating and supervising bioanalytical tasks in the development area of NCEs (New Chemical Entities). Together with your laboratory team you provide the organization with tailored and innovative state-of-the-art bioanalytical methods with the technical focus on liquid chromatography coupled to mass spectrometry to answer key scientific questions of drug development projects. You develop and implement solutions for lab automation and together with our IT experts derive strategies for innovative data management approaches. Moreover, you plan and steer bioanalytical studies and work packages including method development, method validation and sample analysis together with authoring of bioanalytical reports and expert reports for submission. With your expertise, you act as primary contact for our NCE development portfolio projects and work in close collaboration with cross-functional clinical and non-clinical development teams. You actively participate in internal and external scientific communities through presentations, publications, and networking. Doctoral (PhD) degree with major focus on Analytical Chemistry, Food Chemistry, Biochemistry or an equivalent qualification Solid state-of-the-art know-how in analytical sciences including the scientific and technical aspects of bioanalytical studies of small molecules in complex biological matrices Expert in mass spectrometry (LC-MS/MS), preferably in the regulated GLP and GCP environment Excellent communication, presentation, and collaboration skills for the interaction in an international working environment within project teams Team player with excellent team leading skills and the spirit for innovative solutions; curious mind-set and cultural agility A passion to learn, share, contribute, deliver, grow and develop This is where you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.
Zum Stellenangebot


shopping-portal

Hinweis:

Der Internet Explorer wird nicht länger von t-online unterstützt!

Um sicherer und schneller zu surfen, wechseln Sie jetzt auf einen aktuellen Browser.

Wir empfehlen unseren kostenlosen t-online-Browser: